125 Doughty Street, Suite 100 Charleston, SC 29425 843-792-8300 success@musc.edu sctr.musc.edu If you have used any of the SCTR tools, services, or resources listed, your research has been supported by the SCTR Institute, and you must acknowledge the CTSA award in all publications, press releases, posters, or other documents. SCTR NIH Grant Funding Acknowledgement: "This publication [or project] was supported by the South Carolina Clinical & Translational Research (SCTR) Institute, with an academic home at the Medical University of South Carolina, NIH Grant Numbers UL1 RR029882 and UL1 TR000062." RESEARCH TOOLS & RESOURCES ⌘- symbol indicates interactive tools Calendar of Research Events — SCTR posts a calendar of research events on sctr.musc.edu and in the SCTR Weekly email announcement. Contact the SUCCESS Center to add events. Clinical & Translational Research Cores & Facilities Directory — facilitates inter-institutional and interdisciplinary collaborations connecting investigators with tools and services required to develop successful research projects and meaningful collaborations. Clinical Data Warehouse (CDW) — contains electronic clinical data from the OACIS Clinical Data Repository, including patient demographics, ICD-coded diagnoses, ICD-coded procedures, and laboratory test results that can be requested for research use upon IRB approval. ⌘ MAP–R (MUSC Approval Plans for Research) — formulates individual approval plans for research and generates a list of institutional and regulatory approvals needing completion before you can begin your study. Please note: It is helpful to have a protocol in place before you begin using this tool. ⌘ Palmetto Profiles (Find a collaborator) — enables the discovery of research expertise within the Health Sciences South Carolina (HSSC) consortium. This tool allows for new ways to network and collaborate between researchers, mentors and mentees, the research community and industry partners, and much more. Faculty can view and edit their profiles. ⌘ REDCap — General consultations and fee-for-service arrangements are available. ⌘ Database: Secure web based application to support data entry for research studies. o Intuitive interface for data entry (with data validation) o Audit trails for tracking data manipulation and export procedures o Automated export procedures for seamless data downloads to common statistical packages o Procedures for importing data from external sources o Advanced features, such as branching logic and calculated fields Survey: A powerful tool used for building and managing online surveys. You can create and design surveys in your web browser, collect responses from survey participants, and export your survey results into Microsoft Excel or a variety of statistical analysis packages. ResearchMatch (for researchers) — ResearchMatch has a simple goal – to bring together two groups of people who are looking for one another: (1) people who are trying to find research studies, and (2) researchers who are looking for people to participate in their studies. It is free and secure. ⌘ Research Toolkit — An online resource aimed at supporting MUSC researchers in navigating the continuum of the research process. It includes links to forms, guides, and policies from the proposal and budget development stage through study closeout and data dissemination. It is broken in to 3 steps: o Pre-Award- research funding, grant proposal, regulatory, recruitment o Study Conduct – study setup, study conduct, subject protection o Closeout – study closeout, product translation, dissemination SCresearch.org (Clinical Trials Registry) — is the South Carolina Research Studies Directory designed specifically to help interested people locate research studies. This system provides the research team free advertising for recruitment purposes. Only IRB approved studies are made available on SCresearch.org. ⌘ SCTR Weekly — Stay up-to-date with research activities; funding opportunities, and research related events through our weekly email. Study Tracker — Track your study at the patient-level with this secure, web-based tool. Researchers can enter their protocol ID, sponsor, billing contact information, study assessments and participant visits, and payments into the system to track participant activity that has been conducted for their studies. Study summary reports can be generated which display all patients in a particular study, the status of each patient within the study, and the research charges related to each participant visit to facilitate tracking of ongoing study progress. A summary of the work performed and the costs to be billed for each study can be generated along with an invoice letter to the sponsor or billing contact for ease of invoicing. ⌘ RESEARCH SUPPORT SERVICES $ - indicates services that have both free and fee-for-service options TO REQUEST SCTR SERVICES: http://sparc.musc.edu THE SUCCESS CENTER is the “front door” to access all SCTR services. SUCCESS staff are able to link investigators and research team members to additional expert resources within SCTR and/or other institutional agencies, cores, and programs. Specific SUCCESS Services include: Budget Development Core — Grants Navigators will develop the budget for a research study, including identification of all study related costs, coordination of department input and review, creation of study internal budget, and review of study feasibility. After the development of the budget, budget negotiation assistance with the study sponsor will be provided along with a study-tracking template and periodic post-award monitoring of budget issues. $ Grants & Forms Assistance — is hands on training for the completion of grant applications and grant reporting for federal, foundation, or corporate funding. It also includes preparing budget forms, budget justifications, biosketches, resources and environment, progress reports, and other required forms. In-Patient Research Bed Facilitation — Collaborations between SCTR and the hospital created an environment on 8 West conducive to conducting in-patient research. Navigation Services — lead researchers and staff through the complex areas of research at MUSC. This service includes research policy consultations, CTRC proposal pricing, and study site organization. Recruitment Services — are based on your needs and target population. Assistance developing a strategic plan for short or long-term recruitment will be provided including budget planning, ResearchMatch assistance, marketing material development, and partnership facilitation. Regulatory Core Services — Regulatory Coordinators provide individualized training and consultation on regulatory considerations, documentation and processes for submitting to review committees, registering a trial with clinicaltrials.gov, applying for Federal Certificates of Confidentiality (CoC), federal wide assurances, and investigational new drug (IND) and investigational device exemption (IDE) applications. The core also offers investigators the flexibility of contracting regulatory services to process initial study submissions, amendments requests, or continuing review applications. $ Research Coordinator Core (RCC) — is compromised of registered nurses and trained research coordinators. Coordinators are available during normal business hours as well as after hours. They are trained in and adhere to all MUSC policies, ICF, FDA and GCP guidelines. The research coordinators — are available to assist with all aspect of the research process. If you are interested, schedule a consultation with the Research Coordinator Core to see how we can appropriately meet your needs. $40.00 per hour The nurse coordinators (registered nurses) — assist with all of the coordinator tasks as needed and provide guidance on complex studies. In addition, they can perform research tasks such as educating patients on the protocol specifics and study drugs, conducting safety assessments, administering investigational drugs, placing IV’s, accessing lines for labs, and pharmacokinetic sampling. $65.00 per hour Biostatics, Epidemiology, and Research Design (BERD) Program — provides methodological expertise to translational researchers. Services include: Bio-statistical Education Data Analysis Methodology / Study Design Power Analysis / Sample Size Calculation (CTRC) Clinical & Translational Research Center — is a specialized patient care unit whose goal is to both facilitate patient-oriented research in a cost-effective manner and help strengthen the discipline of clinical and translational science by supporting projects and pilot studies that may lead to future NIH or other sources of peer-reviewed clinical/translational research grant support. Services are offered in the areas of: Imaging Laboratory Nursing Nutrition Clinical Research Ethics Program — provides consultations with researchers which result in a written report that covers the background and description of the request, ethical/social/other issues identified, and recommendations for the researcher. Consults are advisory, do not provide mediation, and have no decisionmaking authority. Community Engagement Program — goal is to promote the translation, implementation, diffusion, and adoption of evidence-based treatments and interventions in clinical and community settings, designed to improve the health of diverse populations. Community Research Collaboration Social/Cultural Advisors Community-Based Research Design Community Site Training for Community-Based Research Community-Based Dissemination Efforts General Community Engagement Consult Comparative Effectiveness Research (CER) Program — goal is to systematically assess alternative treatment strategies to improve or maintain health. Comparative effectiveness research differs from traditional clinical research in that it not only tests the efficacy of a particular treatment, but also compares the effectiveness and value of alternative treatment strategies in real-world settings. Consults can provide investigators assistance on CER proposal hypotheses, scientific aims, collaborator identification and/or other technical / scientific needs. Novel Technologies Application Program — goal is to provide investigators with an evaluation of various options for utilization of technology applications in their clinical research studies. Various application systems will be identified and plans developed for enabling their use via software and information systems for mobile phones, personal digital assistants, i-Pod technologies, web based computer assisted programs, interactive call centers, etc. Advances in wireless technologies make it easier to remotely monitor subjects’ biomarkers, multiple physiological function indices, lifestyle behaviors, and medication adherence. Consults are intended to provide assistance with identification of applications which will help the investigative team implement various components of the study in a more cost efficient manner, particularly with subjects in their natural environments. Office of Biomedical Informatics — provides investigators with ready access to a variety of software tools, databases, and support systems. By engaging researchers in the design and development of new tools and research development processes, Biomedical Informatics has substantially increased the innovative use of these systems for translational research. Service available include: RedCap Consultations RedCap Database Development $ RepCap Review $ Bioinformatics Consultation Biomedical Informatics Consultation Legacy Systems Support $ MUSC Research Data Request (CDW) Pilot Project Program — supports the conduct of scientifically meritorious, new, and innovative pilot projects through a competitive grant program. Find out more under Funding Opportunities. Regulatory Knowledge & Support — facilitates the safe, efficient and ethical conduct of clinical and translational research across SCTR by providing focused support for regulatory compliance and management through service and education. See SUCCESS Center Regulatory Services. Training, Education, and Career Development (TEACH) — works to increase the clinical and translational research workforce through innovative educational and mentoring opportunities. See Education / Career Development Opportunities. Translational Technologies & Resources Program — strives to transform the research environment at MUSC and throughout the state by linking the clinically focused core programs with the resources they need to extend their research capability and opportunities for success. This program hosts the Biotechnology Interest Group (BIG) and the Bio Bank Initiative; other resources and services include: SCTR Translational Assistance & Review (STAR) Program: General Scientific and Academic Consults for SCTR Pilot Projects Development – Drugs/Therapeutics Consult Development – Novel Therapeutic Devices Drug/Device Combinations Protocol Development Service Intellectual Property & Patents Core Intellectual Property Consultation Record of Invention (ROI) Patents Request update of ROI and/or Patent from FRD EDUCATION / CAREER DEVELOPMENT Clinical & Translational Research Center Rotations — help students understand the principles and practices of clinical investigation and the process of protocol composition. The combination of lectures, discussions, patient content, and special topic presentations provide an excellent foundation for a career involving clinical & translational research. Core Clinical Research Training — offers live & online course sessions focused on successful clinical research management. Topics range from the rights and safety of human subjects, recruitment and retention outcomes, budget development, and regulatory issues. Fellowship in Clinical Research Ethics / Certificate Program — is designed to provide health professionals who are interested in clinical research ethics with sufficient background to warrant special recognition in the form of a Certificate. Using a variety of instructional methods, participants will gain a broad and deep background in research ethics. Completion is required for those who wish to serve as a MUSC Research Ethics consultant. KL2 Scholars Program — provides mentored, protected research experiences to enhance the development and retention of early career investigators. The program includes an option to pursue a master’s degree in clinical or translational science, a supportive environment, start-up research funds and access to program faculty who will provide expertise and guidance in research design, study coordination, data management, biostatistical analysis, publishing, and grant writing. Clinician Scientist K12 Program - This K12 program supports the career development of scholars holding a research / health-professional doctoral degree or its equivalent. The goal of the program is the same as the goal of the KL2 Program however it is open to investigators with a heavy clinical load due to its requirement of 40% effort Master of Science in Clinical Research — is a specially-designed knowledge and skills building Master Degree program created to provide advanced training in clinical research at MUSC. The objective of this program is to prepare health professionals for research in the clinical setting, emphasizing practical applications of the scientific method of research with less focus on theoretical issues. Southeastern Clinical & Translational Research Training Program (TL1) — is designed to increase the number of well-trained clinical researchers who will assume leadership roles in the design, conduct & oversight of future multidisciplinary clinical investigations. These PhD candidates will be trained to become rigorous, high-quality, and proactive clinical investigators. Research Lunch-N-Learns — are held on the third Wednesday of every month. They address a variety of topics based on the research needs that arise. Other webinars / workshops are offered throughout the year. Many guest lectures are brought to campus and webinars are often presented through organizations such as NCURA and SOCRA. Research Training Opportunities — are listed as a matrix of opportunities for research training and advancement at MUSC through a variety of different sources. Categories of training include: Formal Training, Career Development Awards, Research Seminars, and Other Various Clinical & Translational Research Related Workshops. SCTR Science Retreats — collaborate across disciplinary and institutional lines to host thematic retreats for basic, clinical and population scientists, and community practitioners at all levels of career development. SOCRATES — Society Of Clinical Research And Translational Early Scientists is a forum created to enhance mentoring of junior investigators across the MUSC campus. The group is open to all interested in receiving and providing input on areas such as grantsmanship, science, and study design. One presentation is provided during each meeting followed by questions, comments, and suggestions. FUNDING OPPORTUNITIES SCTR funding supports the conduct of scientifically meritorious, innovative clinical and translational research to accelerate the process from discovery to improved patient care. This includes research support for highly promising early career investigators to shorten the time to research independence. Anticipated Outcome of SCTR Funding: Successful applications to extramural grant funding mechanisms using the preliminary data generated from SCTR funded research to support and sustain the ongoing research Proof-of-concept studies to move laboratory findings toward clinical applicability and/or the dissemination of clinical findings to the community, and development of potential intellectual property and commercialization of technologies as appropriate. Acquisition or use of new technologies or skills PILOT PROJECTS — A master RFA requests submission for grant categories such as Discovery, CommunityUniversity Partnership, Health Disparities, and Fast-Forward Seed Grants, all with the potential to apply with matching funding. In addition, specific RFAs are released to fund pilot projects that would result from SCTR Scientific Retreat participation. CLINICAL & TRANSLATIONAL RESEARCH CENTER — CTRC is a research outpatient clinic providing nursing, nutrition, imaging, and lab services. Services are provided on a fee for service basis and funding support is available. To see if you qualify for assistance please visit: https://sctr.musc.edu/index.php/proprice or call the SUCCESS Center. VOUCHERS — Vouchers enable investigators to gather preliminary data for inclusion in a grant proposal, improve the science or safety of their research projects, or develop a translational focus to their research. SCTR Finance & Administration Office The SCTR Finance & Administration Office manages the finance and administrative activities for the SCTR Institute. Please contact them for questions related to financial management of SCTR Pilot Projects, SCTR Vouchers or CTRC billing. For more information about any of these tool or services, contact the SUCCESS Center at (843) 792-8300 or by e-mail at success@musc.edu Request services and browse our website at https://sctr.musc.edu